Who's who in clinical research

作者：章埴 发布时间：2019-03-07 02:20:02

By Jessica Griggs Acronyms rule in clinical research so it’s easy to get confused. Here’s a quick guide to help you sort out the CRAs from the DSAs Clinical trial administrators (CTAs) handle the paperwork and carry out the general administration to set up a clinical trial and see it through to the end. They may be based at the HQ of the organisation carrying out the trial, or at the trial site. The job is a good way to find out how the clinical research industry works, and while it helps to have a scientific background it is not essential. It used to be possible to move up from CTA level, if you had the right scientific background, but companies are becoming increasingly reluctant to do this as it means having to train another CTA. * Salaries range from £14k to £18k Clinical research associates (CRAs) help develop and implement the structure of and thinking behind the trial. They also liaise with and train the clinicians and researchers at the site of the trial in the trial’s methodology, and check and collect data from the patient and site files. They report back to a project manager. As with most clinical roles, a good degree in life sciences or a healthcare diploma, such as nursing, is usually required, and increasingly a postgraduate qualification may help you stand out from the crowd. CRAs can often control the hours they work, so it can be a good job to combine with other commitments. There is plenty of travel between trial sites, and sometimes internationally if you work for a large company. Because of the nature of the job, you are often provided with a company car, mobile phone and laptop. Companies do take on graduates as trainee CRAs but expect them to have had some kind of industry experience, such as during the industrial placement year of a degree or through a work experience placement shadowing a CRA. Taking external professional courses with a qualification will also show your commitment. Employers will also be looking for skills such as planning, organisation, teamwork and communication in potential candidates. The job is so varied that many people remain as a CRA for a long time without feeling they are stagnating. For those who do want to move on, there is the chance to progress by coaching trainee staff or climbing the industry ladder. Senior CRAs can become project managers, responsible for the design and overall management of a trial, and then on to be programme managers or directors in charge of multiple drug trials or of a therapeutic area. There are also opportunities for CRAs to move into the public sector, such as the UK’s Medical Research Council. Pay is lower, but generous pensions and longer holidays may compensate. * Trainees earn from £20k to £25k, while senior associates can earn between £35k and £40k A doctor and a team of nurses must be on duty at all times during a clinical trial to look after the volunteers and to carry out routine tests. If a career in clinical research appeals more than general medicine, a useful first step for medics who have completed their junior training would be to apply for clinical research jobs in a phase 1 trial at a research hospital. If you have already specialised in a particular field, it would be worth approaching pharmaceutical companies that produce drugs in your area. * Typical salaries for doctors start at £45k to £50k, while nurses range from £26k to £32k Data managers ensure that the information generated by clinical trials is in the right format to be analysed. During the set-up phase of a trial, data managers help decide what data will be needed, and they design special forms, databases and validation checks. Later on, they check data as it comes in, liaising with clinical staff, programmers and statisticians to answer any queries. Aside from excellent IT skills, a good data manager should have an orderly, analytical mind, an eye for detail, and, ideally, an awareness of database design. Bio-statisticians will work out how significant the data is, once it has been processed, and will look for any issues that may only be apparent from analysing the statistical trends. They will have been involved in the design of the drug trial so they can shape the way the results are analysed. A mathematics, statistics or physics degree is usually required. In large companies, the statistical programs and code for representing the data will be written by a programmer specialist in SAS, the software used to analyse most clinical trials. In smaller companies, the biostatistician may also do this. * Starting salaries for both career paths range from £20k to £22k, rising to £30k to £35k after five years Drug safety associates (DSAs) document and track any adverse reactions the volunteers experience during a trial. They are responsible for producing safety reports, which are carefully scrutinised by the company or organisation carrying out the trial, as well as external regulatory bodies. Quality assurance auditors (QAs) make sure the paperwork, both at the setting up stage and the records kept during the trial, are completed to a high standard. This could include checking whether a project manager has the qualifications she or he says they have or ensuring that the correct procedure is followed throughout the trial. QAs need to have a good understanding of safety and confidentiality laws, and of standard operating procedures and regulations, so they should have several years’ professional experience in a clinical trial. Regulatory affairs associates compile and submit the necessary paperwork to the various regulatory bodies before a trial begins so that the trial can be authorised. In the UK approval is needed from at least one research ethics committee and often several specialist committees depending on the nature of the trial; if the trial is being carried out by the NHS then each NHS trust involved needs to give its permission and the trial needs to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). It is also the regulatory affairs associate’s responsibility to apply for a marketing licence for the new drug once it has been reached the appropriate phase. Staff in these last three roles are employed by the company or hospital carrying out the trial, but answer to the external regulatory bodies. This can be a tricky balancing act: you will need good attention to detail, a strong will and the ability to say no. * Typical salaries for these roles start at £20k to £23k, rising to £35k with experience For the first two or three years it is easy to move between departments, but after that you will be expected to start specialising and once you have become established in that area, it becomes harder to transfer. This is especially true of larger companies. In small and medium-sized companies, the job is likely to be more varied. You could be a CRA monitoring the trial but you could also have to do some of the drug safety monitoring, making it easier to change roles. For more information, check out the information provided by the Institute of Clinical Research or the Association of British Pharmaceutical Industry Clinical researchers can end up anywhere from academia, where posts are based at university medical school research units or at hospital research units, to pharmaceutical or biotech companies, or in contract research organisations (CROs), which carry out clinical trials for drug or biotech companies. Working for a CRO will expose recruits to many different phases of clinical trials in diverse therapeutic areas. The pace of work tends to be faster and there is more pressure than at a pharmaceutical company because you are working for a client who will expect the work to be carried out efficiently and to a deadline. Don’t forget that CROs are in the service sector, so you will need top-notch interpersonal skills to deal with clients as well as investigators. If drug discovery really interests you,